Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD

Funding Opportunity Title

Patient Safety Research during Neonatal Care (R03)

Activity Code

R03 Small Grant Program

Announcement Type

New  

Related Notices

  • August 06, 2014 - This PA has been reissued as PA-14-313.
  • Funding Opportunity Announcement (FOA) Number

    PAR-11-226

    Companion FOA

    PAR-11-225, R01 Research Project Grant
    PAR-11-227, R21 Exploratory/Developmental Grant  

    Number of Applications

    See Section III. 3. Additional Information on Eligibility.

    Catalog of Federal Domestic Assistance (CFDA) Number(s)

    93.865

    FOA Purpose

    This FOA encourages a wide range of collaborative research projects related to patient safety in the context of both routine as well as intensive newborn care. The FOA welcomes proposals related to (but not limited to): the epidemiology of various domains of medical errors and consequent patient harm; assessing the factors at various levels that contribute to such errors; and intervention strategies at individual, systems, and institutional-levels to help reduce and eliminate medical errors in the context neonatal care. It is anticipated that knowledge gained from these projects will help develop strategies to deliver highest quality of healthcare to all newborn infants with utmost safety and effectiveness.

    Key Dates
    Posted Date

    June 9, 2011

    Open Date (Earliest Submission Date)

    August 19, 2011

    Letter of Intent Due Date

    August 19, 2011, August 19, 2012, August 19, 2013

    Application Due Date(s)

    September 19, 2011, September 19, 2012, September 19, 2013, by 5:00 PM local time of applicant organization.

    AIDS Application Due Date(s)

    Not Applicable

    Scientific Merit Review

    February/March 2012, February/March 2013, February/March 2014

    Advisory Council Review

    May 2012, May 2013, May 2014

    Earliest Start Date(s)

    July 2012, July 2013, July 2014

    Expiration Date

    September 20, 2013

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

    Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement
    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Purpose

    This FOA encourages a wide range of collaborative research projects related to patient safety in the context of both routine as well as intensive newborn care. The FOA welcomes proposals related to (but not limited to): the epidemiology of various domains of medical errors and consequent patient harm; assessing the factors at various levels that contribute to such errors; and intervention strategies at individual, systems, and institutional-levels to help reduce and eliminate medical errors in the context neonatal care. It is anticipated that knowledge gained from these projects will help develop strategies to deliver highest quality of healthcare to all newborn infants with utmost safety and effectiveness.

    Background

    Over past decade, there has emerged an increased awareness about the need to offer quality care to all patients with utmost safety effectiveness.  Yet, case reports and observational studies continue to report adverse events from medical errors during pediatric healthcare, including routine as well as neonatal intensive care.  For a number of reasons described below, newborn infants may be particularly at higher risk for sustaining injury from medical errors than older patients.  It is also known that healthcare-related errors seldom occur in isolation, and a complex series of factors may operate leading to errors and consequent patient injury. Thus, there is a need for more collaborative research to understand the epidemiology (frequency, causes, types of errors, factors causing them, etc.) and to develop effective prevention strategies that is can be implemented across healthcare facilities in the United States. 

    The need for improving patient safety was highlighted in the Institute of Medicine Report, "To Err is Human: Building a Safer Health System" published in 2000. Since then patient safety issues have received more attention from the scientific community, regulatory agencies, and the general public. However, an expert panel convened by the Eunice Kennedy Shriver National Institute of Child Health and Human Development concluded that more research is needed to address and improve patient safety issues related to neonatal care . This FOA is intended, in part, to fill in knowledge gaps in this important area of pediatric healthcare. 

    Since a many phrases used in the patient safety literature have acquired specific meanings, a few are described below to avoid ambiguity.  "Patient safety" is defined as freedom from accidental injury to anyone who is seeking healthcare.  By establishing operational systems and processes, one attempts to minimize the likelihood of errors and maximize the likelihood of preventing them. "Medical errors" are those due to a failure of the planned action to be completed as intended, or using a wrong plan of action to achieve the goal.  "Medication errors" are  preventable events that  cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professionals, patients,  or consumers. "Adverse events "are injuries and harm resulting from a medical interventions, or lack thereof.   "Near misses" are those errors that do not result in patient harm due to chance or timely interventions.  A "diagnostic error" is a missed, wrong, or delayed diagnosis, detected by later definitive tests, clinical findings, histopathology, or autopsy results. 

    It has also been noted that errors rarely occur from the mistakes of a single individual. Therefore, safety experts recommend a "systems approach" to understand all of the pre-existing factors leading to errors, which would enable developing preventing strategies. 

    Unique Patient Safety Issues in Neonatal Care

    Because of their small size and fragility, and their immaturity of organ systems, newborn infants are uniquely vulnerable for injury from even minor deviations in safe care practices.  Sick newborn infants in the neonatal intensive care units (NICU) are likely to be monitored using a large array of instruments. They are also likely to receive complex levels of care, which can include receiving several medications, undergoing invasive procedures for monitoring, diagnosis and treatment over extended periods of hospitalization. There is also a possibility for receiving care from a team of experts.  All of the above factors tend to increase the potential for errors and patient harm.  There is also a narrow margin of safety; the patients are also more likely to suffer from harmful consequences of errors sooner. Because of their unique vulnerability, even minor errors can lead to devastating short and long-term consequences. In large general hospitals, patient safety efforts are likely to be targeted toward adult patients or treatment units, with little appreciation for the unique needs of the NICUs and their patients.  

    Other identified reasons for increased risk for medical errors in the context of neonatal care include, unfavorable working conditions, healthcare provider fatigue and a large array of  treatment and investigative modalities needed for the care of high-risk newborn infants, can enhance the risk for errors (e.g., ventilator, central catheter, medications, bed-side tests).  Delay due to processing of  specific identification for the newborn infant soon after birth will lead to a necessary paring with the identification of the mother, increasing a chance for misidentification.  Additionally, there is paucity of well-tested, safe and effective devices and instruments for use specifically in the NICU.  These issues may require specific research strategies.

    Several domains of errors and patient harm have been identified in the context of neonatal care.   These include:  medication errors errors;  errors in administration of intravenous parenteral nutrition;  delivery-room resuscitation-related,  ventilator care-related errors; error and harm from invasive procedures, health care–associated infections; patient identification errors; and diagnostic errors.  Other unique types of errors in the NICU include: feeding of the human milk to an infant from a wrong mother, inadvertent administration of human milk intravenously; mix-up in mother-infant identification leading to feeding of infants with the milk of a wrong mother; or discharging an infant to the wrong family.

    Scope

    Thus, research in the field of patient safety during neonatal care is challenging with many  dimensions  that may require the expertise from different fields.  Through this FOA, NIH encourages applications that address a variety of issues in the context of neonatal care. The field and scope of the research proposals sought include, but not limited to:

    Epidemiology of errors and adverse events in the setting of neonatal intensive care

    Medication errors

    Diagnostic errors      

    Procedure-related errors     

    Human factor and fatigue

    Other working conditions and systems issues

    Risk reduction and disclosure practices

    Section II. Award Information
    Funding Instrument

    Grant        

    Application Types Allowed

    New
    Resubmission
    Revision

    The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

    Award Budget

    Budgets for direct costs of up to $50,000 per year for a maximum of $100,000 direct costs over a two-year project period.  

    Award Project Period

     The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

    Section III. Eligibility Information

    1. Eligible Applicants
     
    Eligible Organizations

    Higher Education Institutions:

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    Nonprofits Other Than Institutions of Higher Education

    For profit Organizations

    Governments

    Other

    Foreign (non-U.S.) components of U.S. Organizations are  allowed.

    Required Registrations

    Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

    All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

    All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility

    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

    Section IV. Application and Submission Information

    1. Requesting an Application Package

    Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    Descriptive title of proposed research
    Name, address, and telephone number of the PD(s)/PI(s)
    Names of other key personnel
    Participating institutions
    Number and title of this funding opportunity

    The letter of intent should be sent to:

    Tonse N. K. Raju, MD
    Pregnancy and Perinatology Branch, CDBPM
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    6100 Executive Boulevard, Room 4B03
    Bethesda, MD 20892-7510
    For FedEx: Rockville, MD 20852
    Telephone: 301- 402-1872
    Fax: 301-496-6790
    Email: rajut@mail.nih.gov

    Required and Optional Components

    The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

    PHS 398 Research Plan Component

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Resource Sharing Plan

    Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

    Appendix

    Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    Foreign Organizations

    Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

    3. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

    Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

    Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    4. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    5. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

    6. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

    Important reminders:
    All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.  

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

    Section V. Application Review Information

    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    For this particular announcement, note the following:

    The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

    Overall Impact

    Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

    Investigator(s)    

    Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

    If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?        

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    Inclusion of Women, Minorities, and Children 

    When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    Not Applicable

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

    Applications from Foreign Organizations

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information

    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

    Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

     A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
    Contact Center Phone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Telephone 301-435-0714
    TTY 301-451-5936
    Email: GrantsInfo@nih.gov

    eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
    Phone: 301-402-7469 or 866-504-9552 (Toll Free)
    TTY: 301-451-5939
    Email: commons@od.nih.gov

    Scientific/Research Contact(s)

    Tonse N. K. Raju, MD
    Pregnancy and Perinatology Branch (PPB)
    Center for Developmental Biology and Perinatal Medicine (CDBPM)
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    6100 Executive Boulevard, Room 4B03
    Bethesda, MD 20892-7510
    Rockville, MD 20852 (for express/courier service; non-USPS service)
    Telephone: 301- 402-1872
    Fax: 301-496-6790
    Email: rajut@mail.nih.gov

    Peer Review Contact(s)

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Financial/Grants Management Contact(s)

    Bryan S. Clark, MBA
    Chief, Grants Management Branch
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    6100 Executive Boulevard
    Bethesda, MD 20892-7510
    Rockville, MD 20852 for courier/non-USPS service
    Telephone:  301-435-6975
    Email:  clarkb1@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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